IMMUNO-LUNG : Identification of Biomarkers and Therapeutic Targets for Pulmonary Immunotherapy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitut Paoli-Calmettes

About this trial

Immunotherapy has helped improve the prognosis of metastatic lung cancer. However, only about 40% of patients respond to conventional immunotherapy with anti-PD(L)-1 agents. This research aims to identify biomarkers of response to immunotherapy at the tumor level and to characterize new therapeutic targets

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged 18 years or older, male or female.

Willing to participate in the study and having signed a written informed consent form.

Presenting a strong suspicion of localized resectable or advanced unresectable non-small cell lung cancer, or having a histologically confirmed non-small cell lung cancer.

Affiliated with a social security system or benefiting from such a system.

Disqualifiers

Individuals in an emergency situation, adults under legal protection (guardianship, curatorship, or judicial protection), or individuals unable to provide informed consent.

Inability to comply with the medical follow-up required by the study for geographical, social, or psychological reasons.

History of solid organ transplantation or hematopoietic stem cell transplantation.

Pregnant or breastfeeding women.

Trial design

Design model

Parallel

Treatments tested in this trial

  • prospective collection of blood and tumor samples

    Procedure/Surgery

    The procedure under study is based on the collection of tissue and blood samples at two time points during the patient's management. The patient will undergo a first sampling at the time of inclusion in the study, followed by a second sampling performed at the time of disease progression. Two types of samples will be collected: blood samples and tumor samples. The protocol-mandated tumor sampling at progression will be performed in the following two situations: 1. If, as part of routine clinical care, a biopsy is planned, an additional tumor sample for the study will be collected. 2. If the patient has consented to undergoing a protocol-specific tumor biopsy at the time of progression

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: patients with localized NSCLCOther 1 intervention
Group B: patients with advanced NSCLCOther 1 intervention

Trial outcomes

Primary outcomes

1

"The primary objective is to assess the association between the immune signature in peripheral blood and the efficacy of immunotherapies in patients with advanced-stage NSCLC

Overall survival of patients with advanced-stage NSCLC treated with immunotherapy according to their immune signature.

Time frame
until the patient's death"or until the end of the patient follow-up period, which is 60 months

Secondary outcomes

1

Compare immune biomarkers in the blood and in the tumor microenvironment of NSCLC patients

Frequency of Immune Biomarkers in the Blood and Tumor Microenvironment of NSCLC

Time frame
through study completion, an average of 7 year
2

Compare the expression of immune biomarkers in the tumor microenvironment of localized versus advanced NSCLC

Frequency of Immune Biomarkers in the Tumor Microenvironment of Localized and Advanced NSCLC

Time frame
through study completion, an average of 7 year
3

Identify new immune biomarkers predictive of immunotherapy efficacy in advanced NSCLC

Frequency of Novel Immune Biomarkers According to Response to Immunotherapies in Advanced NSCLC

Time frame
through study completion, an average of 7 year
4

Study the HVEM/BTLA axis in localized and advanced NSCLC

Association between HVEM expression and overall survival in localized and advanced NSCLC

Time frame
through study completion, an average of 7 year

Other outcomes

Sponsors and contacts

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